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Wet Age Related Macular DegenerationNCT01899963

Time to Treatment Utilizing a Tele-Retinal Referral System for wAMD and DME: A Pilot Study

An observational study of Wet Age Related Macular Degeneration and Diabetic Macular Edema, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this province, optometrists are often responsible for contacting the retinal specialists' office to arrange patients to be examined for suspected emergencies or more routine referrals related to the eye. Read more about this study

Who is it for?
Ages 18 years and older
How many people
83 participants
Where
1 siteCanada
Study dates
Nov 2013to Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population includes patients who are referred from an optometrist either participating in the teleophthalmology referral system or via conventional fax referrals with a provisional diagnosis of possible wet AMD or DME to any of the physician investigators.

Who may be able to join

  • Aged greater than 18 years,
  • Able to provide informed consent,
  • Referred from an optometrist either participating in the teleophthalmology referral system or via conventional fax referrals with a provisional diagnosis of possible wet AMD or DME to any of the physician investigators.

Who cannot join

  • Patients with a presumed diagnosis of wet AMD and/or DME at the time of referral who previously had diagnostic imaging (ex. fundus images, OCT images) performed as part of the referral will be excluded;
  • Patients unable to tolerate fluorescein angiography (FA);
  • Patients unable to travel to the retina practice for treatment or further testing,
  • Patients unable to fully understand the study requirements and provide informed consent.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St. Joseph's Healthcare Hamilton King Campus

    Hamilton, Ontario, L8G5E4

Other trials in Canada

About this study

Official title: Time to Treatment Utilizing a Tele-Retinal Referral System for Wet Age Related Macular Degeneration and Diabetic Macular Edema: A Pilot Study

In this province, optometrists are often responsible for contacting the retinal specialists' office to arrange patients to be examined for suspected emergencies or more routine referrals related to the eye. This is often done by faxing a referral form to the specialists' office, where the retinal specialist will examine the information presented in the referral form and make a decision on when the patient should be seen. This current method has some important considerations, such as the difficulty of transmitting clear images of the back of the eye over fax. Having this information could help the retinal specialist in determining when the patient should be seen, especially in terms of booking additional tests or when treatment should be given.

Teleophthalmology is a branch of telemedicine that delivers eye care through digital equipment and telecommunications technology. It offers some unique advantages, such as the ability to be integrated with electronic health records, the ability to be viewed by multiple members of the health care team, and potentially reduce wait times and travel times to the ophthalmologist.

However, there is no comparison known to the study team between whether patients being referred from optometrists to retina specialists through a teleophthalmology system will be treated earlier than patients through a conventional fax system. This study aims to examine and provide more information on this topic.

Read the detailed description

Within the province of Ontario, there are a limited number of retinal specialists for a large and geographically diverse population of 13.5 million people in 2012. Because the majority of these specialists are located in larger urban centers, many rural patients have difficulty travelling the significant distance from their communities to the city. Currently in Ontario optometrists are responsible for triaging retinal eye diseases; emergency referrals such as endophthalmitis are organized by same-day telephone consultations, while more routine referrals are scheduled by fax.

This current method of triage has particular important considerations. Because of the limited number of retinal specialists long wait times can lead to permanent vision loss if the referral is inaccurate, where the patient should have been seen and treated sooner instead of later such as the case of wet age-related macular degeneration (wAMD) and Diabetic Macular Edema (DME). In addition, essential vision tests such as fluorescein angiography (FA) are often available only in a hospital setting rather within physician or optometrists' office. For patients from rural or remote communities, this inconvenience could result in lost wages, a long return trip back the next day or even an overnight stay.

Teleophthalmology is a branch of telemedicine that delivers eye care through digital equipment and telecommunications technology. It offers some unique advantages, such as the ability to be integrated with electronic health records, the ability to be viewed by multiple members of the health care team, and potentially reduce wait times and travel times to the ophthalmologist. Within Canada, there have been different teleophthalmology initiatives to provide access to specialists to optometrists and primary care practitioners particularly in rural and remote areas, improving ophthalmologic care and reducing unnecessary patient travel expenditures. These teleophthalmology systems can include fundus and Optical Coherence Tomography (OCT) images to aid the ophthalmologist in more accurately diagnosing and triaging the referral. Hanson et al. in a retrospective case series noted that tele-referrals to retinal specialists from optometrists reduced average travel time, travel distance and the number of office visits to retina specialists while improving efficiency of clinical examination, testing, and treatment.

However, there currently is no research known to the study team that actively compares the time to treatment for patients based on teleophthalmology referral and assessment versus a conventional paper referral system from optometrists to retinal specialists. For conditions like wAMD and DME related to Diabetic Retinopathy that are often referred via teleophthalmology, the difference in time to treatment could prevent vision loss. The inclusion of fundus and OCT images in teleophthalmology could also improve triage accuracy and prioritization of referrals and appointments to the retinal specialist. This study focuses on comparing the time to treatment for a tele-retinal referral system to a paper referral system by focusing on two prevalent retinal conditions: wet AMD and DME. The results could demonstrate that tele-ophthalmology can reduce the time to treatment for patients with wet AMD and DME in Ontario, improving access to retinal specialists and allowing for more efficient triage of patients.

Keywords
wet Age Related Macular Degeneration, Diabetic Macular Edema, Telemedicine, Teleophthalmology, Time to Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01899963
Study groupRoleWhat they receive
Tele-ophthalmology Referral GroupThis group includes patients referred to a retinal specialist via a teleophthalmology referral system.
Conventional Referral GroupThis group includes patients referred to a retinal specialist via a conventional fax system.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Treatment

    Defined as defined as the time between when the retina specialist reviews the information collected by either system to when the patient receives treatment by the specialist in the clinic.

    Measured: Average 5-6 Weeks.

Secondary outcomes (5)
  1. Maximum wait time

    Maximum time between assessment and further assessment, testing, or treatment.

    Measured: Can range from 2-6 weeks.

  2. Minimum Wait Time

    Minimum time between assessment and further assessment, testing, or treatment for patients in either cohort.

    Measured: Can range from 2-6 weeks.

  3. Mean wait time

    Mean time between patients of a single cohort for further assessment, testing, or treatment.

    Measured: Can range from 2-6 weeks.

  4. Travel time

    This will serve to examine if there is a decreased frequency of visits and subsequently reduced travel time for office visits, for assessment, treatment, or testing for the ophthalmology referral group compared to the fax referral group.

    Measured: Can range from 30 minutes or greater.

  5. Travel Distance

    This will serve to examine if there is a decreased frequency of travel in terms of distance for office visits for assessment, treatment, or testing for the ophthalmology referral group compared to the fax referral group.

    Measured: Can range from 1 kilometer or greater.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionJan 2022
  4. Study completionFeb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01899963
Sponsor's protocol ID
Tele-retinal Referral T.T.T.
Status last verified
May 2023
First submitted
9 Jul 2013
Last updated
22 May 2023
Results posted
No
Data monitoring committee
No

Publications

  • Nanji K, Fung M, Qian J, Khan M, Barbosa J, Chaudhary V. Comparing an electronic clinical information transfer system to traditional fax referrals for patients with suspected neovascular age-related macular degeneration or diabetic macular edema. Can J Ophthalmol. 2024 Oct;59(5):e614-e615. doi: 10.1016/j.jcjo.2024.03.020. Epub 2024 Apr 15. No abstract available.

    PubMed 38636554

Questions about this trial

What is this clinical trial studying?

An observational study of Wet Age Related Macular Degeneration and Diabetic Macular Edema, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Treatment (time frame: Average 5-6 Weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01899963, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.

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